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  • MFDS, published COVID-19 vaccine clinical trial guidelines
  • by Lee, Tak-Sun | translator Choi HeeYoung | Jun 18, 2020 06:28am
K-Vaccine Rapid Review Promotion Group prepared and supported for commercialization
The MFDS announced on the 16th that it has published guidelines to help early entry into the clinical trial of COVID-19 vaccine and support its commercialization.

The main contents are: ¡ãrequirements for quality data of clinical trial drugs ¡ãconsiderations for non-clinical studies such as toxicity tests cConsiderations for the first clinical trial ¡ãconsiderations for setting safety, efficacy, and immunogenicity evaluation items ¡ãThe World Health Organization (WHO)¡¯s COVID-19 vaccine Guidelines (Appendix).
 ¡ã Development status of COVID-19 vaccines

Meanwhile, the MFDS provides customized consultations to 11 companies developing COVID-19 vaccines through the 'Rapid Examination Promotion Group for K-Vaccine' and supports them to quickly enter the clin
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